Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions

Example SubstanceDefinition: 278736ef-2ddf-49e4-895c-3a9f34db36cf

Generated Narrative: SubstanceDefinition

Resource SubstanceDefinition "278736ef-2ddf-49e4-895c-3a9f34db36cf"

Profile: Excipient Drug Substance

identifier: Cochineal

classification: Chemical (PQ-CMC-FDA Temporary Codes#C48807)

grade: Company Standard (PQ-CMC-FDA Temporary Codes#C134009)

Codes

-Code
*TZ8Z31B35M (Unique Ingredient Identifier (UNII)#TZ8Z31B35M)

Names

-NameTypePreferred
*CochinealGSRS Preferred Term (PQ-CMC-FDA Temporary Codes#C203355)true

SourceMaterials

-TypeGenusSpeciesCountryOfOrigin
*Chemical (PQ-CMC-FDA Temporary Codes#C48807)Dactylopius ()cochineal ()Turkey (ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code#TUR)